Other products from "ELITECHGROUP MDX LLC"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 03661540952418 M800739 The MGB Alert Internal Control MS2 DNA Template consists of a DNA plasmid intend The MGB Alert Internal Control MS2 DNA Template consists of a DNA plasmid intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The MS2 Internal Control can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The internal control is not intended to monitor other real-time PCR processes. OLD Internal Polymerase Chain Reaction Control, Not Assay Specific 1 MGB Alert MS2 Internal Control DNA Template (250uL volume)
2 03661540951886 800438 800438 "MGB Alert® B. pertussis / B. parapertussis Probe Mix is an analyte specific rea "MGB Alert® B. pertussis / B. parapertussis Probe Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designedto detect nucleic acid sequences from the insertion sequence IS481 in Bordetella pertussis and insertion sequence IS1001 in Bordetella parapertussis.The mix consists of two probes at 1.12 nmol per vial in a 1X TE buffer solution. The probes are labeled with 6-carboxyfluorescein, which has anexcitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm." MVU Reagents, Specific, Analyte 1 MGB Alert® Bordetella P/PP Probe Mix ASR - 48 Reactions
3 03661540951787 M800331 M800331 The MGB Alert PCR Master Mix package includes ready to use 2x master mix contain The MGB Alert PCR Master Mix package includes ready to use 2x master mix containinga non-Taq thermostable enzyme lacking exonuclease activity and provided in antibodyinactivated form. An initial high-temperature incubation step denatures the antibodies toactivate the enzyme. The master mix also includes Uracil-DNA Glycosylase (UDG) anddUTP to prevent carry-over contamination. MGB Alert PCR Enhancer and MGB Alert 25 mMMgCl2 are provided for additional flexibility in optimizing reaction conditions. PPM General Purpose Reagent 1 MGB Alert 2X PCR Master Mix 48 rxn
4 03661540951770 800434 800434 MGB Alert® Chlamydophila pneumoniae Probe is an analyte specific reagent that co MGB Alert® Chlamydophila pneumoniae Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the Major Outer Membrane protein gene region of Chlamydophila pneumoniae. The mix consists of one probe at 0.72 nmol per vial in a 1X TE buffer solution. The probe is labeled with fluorescein (FAM) and has an excitation wavelength maxima of 496 nm and an emission wavelength maxima of 517 nm. MVU Reagents, Specific, Analyte 1 MGB Alert® Chlamydophila Pneumoniae Probe Mix ASR - 48 Reactions
5 03661540951633 800439 800439 The MGB Alert Internal Control Set IC1-V consists of reagents intended for use a The MGB Alert Internal Control Set IC1-V consists of reagents intended for use as an unassayed internal extraction and amplificationprocess control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC1-V can be used to detectsystemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set isnot intended to monitor other real-time PCR processes. OLD Internal Polymerase Chain Reaction Control, Not Assay Specific 1 MGB Alert Internal Control Set IC1-V 48 rxn
6 03661540951626 800432 800432 The MGB Alert Internal Control Set IC2-C consists of reagents intended for use a The MGB Alert Internal Control Set IC2-C consists of reagents intended for use as an unassayed internal extraction and amplificationprocess control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2-C can be used to detectsystemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set isnot intended to monitor other real-time PCR processes. OLD Internal Polymerase Chain Reaction Control, Not Assay Specific 1 MGB Alert Internal Control Set IC2-C-480 rxn
7 03661540951534 800421 800421 "MGB Alert® BK Virus Probe Mix is an analyte specific reagent that contains a ch "MGB Alert® BK Virus Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleicacid sequences from BK Virus. The mix consists of one probe at 1.5 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm." MVU Reagents, Specific, Analyte 1 MGB Alert® BKV Probe Mix ASR-48rxn
8 03661540951527 800419 800419 "MGB Alert® VZV Probe Mix is an analyte specific reagent that contains a chemica "MGB Alert® VZV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acidsequences within the ORF 38 region of VZV(Varicella-Zoster Virus). The mix consists of one probe at 0.5 nmol per vial in a 1X TE buffer solution. Theprobe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm." MVU Reagents, Specific, Analyte 1 MGB Alert® VZV Probe Mix ASR - 48 rxn
9 03661540951442 800365 800365 The MGB Alert Internal Control Set MS2-E consists of reagents intended for use a The MGB Alert Internal Control Set MS2-E consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set MS2-E can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes. OLD Internal Polymerase Chain Reaction Control, Not Assay Specific 1 MGB Alert Internal Control Set MS2-E
10 03661540951411 800362 800362 The MGB Alert Internal Control Set IC2 consists of reagents intended for use as The MGB Alert Internal Control Set IC2 consists of reagents intended for use as an unassayed internal extraction and amplificationprocess control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2 can be used to detect systemicvariation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is notintended to monitor other real-time PCR processes. OLD Internal Polymerase Chain Reaction Control, Not Assay Specific 1 MGB Alert Internal Control Set IC2-480 rxn
11 03661540951367 800349 800349 MGB Alert® HSV Probe is an analyte specific reagent that contains a chemically s MGB Alert® HSV Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from HSV (Herpes Simplex Virus). The mix consists of one probe at 4.96 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm. MVU Reagents, Specific, Analyte 1 MGB Alert HSV Ensemble Probe Mix ASR - 480 rxn
12 03661540951220 M800687 M800687 "MGB Alert® Pan Legionella Probe is an analyte specific reagent that contains a "MGB Alert® Pan Legionella Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the ssrAgene region of Legionella micdadei. The mix consists of one probe at 1.44 nmol per vial in a 1X TE buffer solution. The probe is labeled with AP525 andhas an excitation wavelength maxima of 527 nm and an emission wavelength maxima of 549 nm" MVU Reagents, Specific, Analyte 1 MGB Alert® Pan Legionella Probe Mix ASR - 48 Reactions
13 03661540950254 M800580-am M800580-am The MGB Alert Internal Control Set IC2-T consists of reagents intended for use a The MGB Alert Internal Control Set IC2-T consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2-T can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes. OLD Internal Polymerase Chain Reaction Control, Not Assay Specific 1 MGB Alert Internal Control Set IC2-T, 09N42-001
14 03661540950247 M800580 M800580 The MGB Alert Internal Control Set IC2-T consists of reagents intended for use a The MGB Alert Internal Control Set IC2-T consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2-T can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes. OLD Internal Polymerase Chain Reaction Control, Not Assay Specific 1 MGB Alert Internal Control Set IC2-T
15 03661540950162 800497-am 800497-am MGB Alert® Adenovirus Primer Mix contains chemically synthesized DNA oligonucleo MGB Alert® Adenovirus Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Adenovirus.The mix consists of a total of 3.3 nmol of primers per vial in a 1X TE buffer solution. The primers amplify the hexon gene, which covers all knownAdenovirus types. MVU Reagents, Specific, Analyte 1 MGB Alert Adenovirus Primer Mix ASR, 09N40-003
16 03661540950148 800424-am 800424-am MGB Alert® EBV Probe Mix is an analyte specific reagent that contains a chemical MGB Alert® EBV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from EBV (Epstein-Barr Virus). The mix consists of one probe at 0.5 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm. MVU Reagents, Specific, Analyte 1 MGB Alert EBV Probe Mix ASR, 09N39-002
17 03661540950025 1 HSV 1&2 ELITe MGB Assay for the detection of HSV. A collection of reagents and HSV 1&2 ELITe MGB Assay for the detection of HSV. A collection of reagents and other materials intended to be used for the qualitative detection of nucleic acid from herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) in a clinical specimen, using a nucleic acid technique (NAT). This is a qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. PGI Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutane Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples 2 HSV 1&2 ELITe MGB Assay
18 03661540950018 M800552 M800552 The United States (US) Food and Drug Administration (FDA) has issued an Emergenc The United States (US) Food and Drug Administration (FDA) has issued an Emergency UseAuthorization (EUA) to authorize the use of the Zika ELITe MGB® Kit U.S. for the in vitroqualitative detection of Zika virus with specified instruments. This assay tests for Zika virusRNA in human serum and EDTA plasma. Zika ELITe MGB® - EUA
19 03661540951275 800332 800332 MGB Alert® BK Virus Primer Mix contains chemically synthesized DNA oligonucleoti MGB Alert® BK Virus Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from BK Virus. The mix consists of a total of 2.6 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 72 nucleic acid sequence from the VP1 region of BK Virus. MVU Reagents, Specific, Analyte 1 MGB Alert® BKV Primer Mix ASR - 480 Reactions
20 03661540952388 M800736 M800736 The MGB Alert Internal Control IC1 Template consists of a DNA plasmid intended f The MGB Alert Internal Control IC1 Template consists of a DNA plasmid intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The IC1 Internal Control can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The internal control is not intended to monitor other real-time PCR processes. OLD Internal Polymerase Chain Reaction Control, Not Assay Specific 1 MGB Alert IC1 Internal Control Template
21 03661540952326 M800733 MGB Alert® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligo MGB Alert® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligonucleotides designed to detect nucleic acids from the BKVirus. MVU Reagents, Specific, Analyte 1 MGB Alert® BKV ASR v3.0 Probe Mix
22 03661540951824 M800694 M800694 "The MGB Alert Platinum Master Mix is intended for use in the development of lab "The MGB Alert Platinum Master Mix is intended for use in the development of laboratory assays whichtarget DNA analytes using real-time PCR. The MGB Alert Platinum Master Mix itself generates nodiagnostic information or data." PPM General Purpose Reagent 1 MGB Alert Platinum Master Mix with water-480rxn
23 03661540951503 800416 800416 MGB Alert® HSV 1 & 2 Primer Mix contains chemically synthesized DNA oligonucleot MGB Alert® HSV 1 & 2 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HSV 1 and 2(Herpes Simplex Virus 1 & 2). The mix consists of a total of 1.5 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 54 nucleicacid sequence from the glycoprotein D region of HSV 1 and 2. MVU Reagents, Specific, Analyte 1 MGB Alert HSV 1&2 Typer Primer Mix ASR - 48 rxn
24 03661540951602 800430 800430 The MGB Alert Internal Control Set IC2-B consists of reagents intended for use a The MGB Alert Internal Control Set IC2-B consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2-B can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes. OLD Internal Polymerase Chain Reaction Control, Not Assay Specific 1 MGB Alert® Internal Control Set IC2-B, 48 rxn
25 03661540951480 800414 800414 "MGB Alert® EBV Primer Mix contains chemically synthesized DNA oligonucleotides "MGB Alert® EBV Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from EBV (Epstein-BarrVirus). The mix consists of a total of 3.1 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 61 nucleic acid sequence from thep140 region of the BNRF1 gene of EBV." MVU Reagents, Specific, Analyte 1 MGB Alert® EBV Primer Mix ASR - 48 Reactions
26 03661540951435 800364 800364 The MGB Alert Internal Control Set MS2-M consists of reagents intended for use a The MGB Alert Internal Control Set MS2-M consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set MS2-M can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes. OLD Internal Polymerase Chain Reaction Control, Not Assay Specific 1 MGB Alert Internal Control Set MS2-M 48 rxn
27 03661540950360 M800602 M800602 "MGB Alert® JC Virus Probe is an analyte specific reagent that contains a chemic "MGB Alert® JC Virus Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the VP2 Tantigen region of JC Virus. The mix consists of one probe at 0.72 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 496 nm and an emission wavelength maxima of 517 nm." MVU Reagents, Specific, Analyte 1 MGB Alert® JCV Probe Mix ASR - 48 Reactions
28 03661540950216 M800582-am M800582-am MGB Alert® Trichomonas vaginalis Probe is an analyte specific reagent that conta MGB Alert® Trichomonas vaginalis Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect arepeated DNA fragment in Trichomonas vaginalis. The mix consists of one probe at 0.56 nmol per vial in a 1X TE buffer solution. The probe is labeledwith 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm. MVU Reagents, Specific, Analyte 1 MGB Alert Trichomonas Vaginalis Probe Mix ASR, 09N42-002
29 03661540950117 800421-am 800421-am MGB Alert® BK Virus Probe Mix is an analyte specific reagent that contains a che MGB Alert® BK Virus Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleicacid sequences from BK Virus. The mix consists of one probe at 1.5 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm. MVU Reagents, Specific, Analyte 1 MGB Alert BK Virus Probe Mix ASR, 09N38-002
30 03661540952357 M800727 MGB Alert® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligo MGB Alert® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligonucleotides designed to detect nucleic acids from the BKVirus. The mix consists of a total of 0.64 nmol of DSQ probe per vial in a 1X TE buffer solution. The probe is specific to a region of the majorcapsid protein VP1 gene of the BK Virus. MVU Reagents, Specific, Analyte 1 MGB Alert® BKV ASR v3.0 Probe Mix
31 03661540951862 800361 800361 The MGB Alert Internal Control Set IC1-C consists of reagents intended for use a The MGB Alert Internal Control Set IC1-C consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC1-C can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes OLD Internal Polymerase Chain Reaction Control, Not Assay Specific 1 MGB Alert®Internal Control 1C Set, 480 rxn
32 03661540951794 M800599-am M800599-am The MGB Alert Platinum Master Mix is intended for use in the development of labo The MGB Alert Platinum Master Mix is intended for use in the development of laboratory assays which target DNA analytes using real-time PCR. The MGB Alert Platinum Master Mix itself generates no diagnostic information or data. PPM General Purpose Reagent 1 MGB Alert Platinum Master Mix, 09N41-005
33 03661540951374 800350 800350 "MGB Alert® CMV 3.0 Primer Mix contains chemically synthesized DNA oligonucleoti "MGB Alert® CMV 3.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from the IE1 regionof CMV (Cytomegalovirus). " MVU Reagents, Specific, Analyte 1 MGB Alert® CMV 3.0 Primer Mix ASR - 480 Reaction
34 03661540951664 800497 800497 MGB Alert® Adenovirus Primer Mix contains chemically synthesized DNA oligonucleo MGB Alert® Adenovirus Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Adenovirus.The mix consists of a total of 3.3 nmol of primers per vial in a 1X TE buffer solution. The primers amplify the hexon gene, which covers all knownAdenovirus types. MVU Reagents, Specific, Analyte 1 MGB Alert® Adenovirus Primer Mix ASR - 48 rxn
35 03661540951510 800418 800418 "MGB Alert® VZV Primer Mix contains chemically synthesized DNA oligonucleotides "MGB Alert® VZV Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from VZV (VaricellaZoster Virus). The mix consists of a total of 3.5 nmol of primers per vial in a 1X TE buffer solution. The primers amplify the VZV sequence within theORF 38 region." MVU Reagents, Specific, Analyte 1 MGB Alert® VZV Primer Mix ASR - 48 rxn
36 03661540951459 800404 800404 "MGB Alert® CMV 3.0 Probe Mix is an analyte specific reagent that contains a che "MGB Alert® CMV 3.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleicacid sequences from CMV (Cytomegalovirus). The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm andan emission wavelength maxima of 516 nm. " MVU Reagents, Specific, Analyte 1 MGB Alert® CMV 3.0 Probe Mix ASR - 480 Reactions
37 03661540951329 800337 800337 MGB Alert® Enterovirus Probe Mix is an analyte specific reagent that contains a MGB Alert® Enterovirus Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from Enterovirus. The mix consists of one probe at 0.14 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm. MVU Reagents, Specific, Analyte 1 MGB Alert® Enterovirus Probe Mix ASR - 48 Reactions
38 03661540951251 800306 800306 "MGB Alert® hMPV Primer Mix contains chemically synthesized DNA oligonucleotides "MGB Alert® hMPV Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from hMPV (humanMetapneumovirus). The mix consists of a total of 8.4 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 186 nucleic acidsequence from the Polymerase (L) gene of hMPV." MVU Reagents, Specific, Analyte 1 MGB Alert® hMPV Primer Mix ASR - 48 Reactions
39 03661540950322 M800600 M800600 The MGB Alert Internal Control Set IC2-8 consists of reagents intended for use a The MGB Alert Internal Control Set IC2-8 consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2-8 can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes. OLD Internal Polymerase Chain Reaction Control, Not Assay Specific 1 MGB Alert Internal Control Set IC2-8 48 rxn
40 03661540950193 M800331-am M800331-am The MGB Alert PCR Master Mix package includes ready to use 2x master mix contain The MGB Alert PCR Master Mix package includes ready to use 2x master mix containinga non-Taq thermostable enzyme lacking exonuclease activity and provided in antibodyinactivated form. An initial high-temperature incubation step denatures the antibodies toactivate the enzyme. The master mix also includes Uracil-DNA Glycosylase (UDG) anddUTP to prevent carry-over contamination. MGB Alert PCR Enhancer and MGB Alert 25 mMMgCl2 are provided for additional flexibility in optimizing reaction conditions. PPM General Purpose Reagent 1 MGB Alert PCR Master Mix 09N41-004
41 03661540950179 800498-am 800498-am MGB Alert® Adenovirus Probe Mix is an analyte specific reagent that contains che MGB Alert® Adenovirus Probe Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to detect nucleicacid sequences within the hexon gene, which is present in all known Adenovirus types. The mix consists of two probes at 1.12 nmol per vial in a 1X TEbuffer solution. The probes are labeled with 6-carboxyfluorescein, which has an excitation wavelength maxima of 492 nm and an emission wavelengthmaxima of 516 nm. MVU Reagents, Specific, Analyte 1 MGB Alert Adenovirus Probe Mix ASR, 09N40-002
42 03661540950087 M800587-am M800587-am MGB Alert® HSV Typer AS Primer Mix contains chemically synthesized DNA oligonucl MGB Alert® HSV Typer AS Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HSV 1and 2 (Herpes Simplex Virus 1 & 2). The mix consists of a total of 1.0 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 54nucleic acid sequence from the glycoprotein D region of HSV 1 and 2. MVU Reagents, Specific, Analyte 1 MGB Alert HSV-2 Primer Mix ASR 09N45-003
43 03661540950049 M800572 M800572 MGB Alert® Pneumocystis Probe Mix is an analyte specific reagent that contains a MGB Alert® Pneumocystis Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detectnucleic acid sequences from Pneumocystis jirovecii. The mix consists of one probe at 0.56 nmol of probe per vial in a 1X TE buffer solution. The probeis labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 496 nm and an emission wavelength maxima of 517 nm. MVU Reagents, Specific, Analyte 1 MGB Alert Pneumocystis Probe Mix 48rxn,
44 03661540950001 M800346 MRSA/SA ELITe MGB™ is a qualitative in vitro diagnostic test for the direct dete MRSA/SA ELITe MGB™ is a qualitative in vitro diagnostic test for the direct detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA purified from nasal swabs. MRSA/SA ELITe MGB™ is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections or to guide or monitor treatment for MRSA infections. A negative result does not preclude MRSA/SA nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing. NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococc System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen 2 MRSA/SA ELITe MGB
45 03661540951466 800411 MGB Alert® BK Virus Primer Mix contains chemically synthesized DNA oligonucleoti MGB Alert® BK Virus Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from BK Virus. The mix consists of a total of 2.6 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 72 nucleic acid sequence from the VP1 region of BK Virus. MVU Reagents, Specific, Analyte 1 MGB Alert® BKV Primer Mix ASR - 48 Reactions
46 03661540951817 M800693 M800693 The MGB Alert Platinum Master Mix is intended for use in the development of labo The MGB Alert Platinum Master Mix is intended for use in the development of laboratory assays which target DNA analytes using real-time PCR. The MGB Alert Platinum Master Mix itself generates no diagnostic information or data. PPM General Purpose Reagent 1 MGB Alert Platinum Master Mix, with water-48rxn
47 03661540951596 800429 800429 The MGB Alert Internal Control Set IC2 consists of reagents intended for use as The MGB Alert Internal Control Set IC2 consists of reagents intended for use as an unassayed internal extraction and amplificationprocess control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2 can be used to detect systemicvariation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is notintended to monitor other real-time PCR processes. OLD Internal Polymerase Chain Reaction Control, Not Assay Specific 1 MGB Alert Internal Control Set IC2-48rxn
48 03661540951572 800426 800426 MGB Alert® HSV 1 & 2 Probe Mix is an analyte specific reagent that contains a ch MGB Alert® HSV 1 & 2 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleicacid sequences from HSV 1 and 2 (Herpes Simplex Virus 1 and 2). The mix consists of one probe at 0.2 nmol per vial in a 1X TE buffer solution. Theprobe dye is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm. MVU Reagents, Specific, Analyte 1 MGB Alert HSV 1&2 Typer Probe Mix ASR - 48 rxn
49 03661540951350 800348 800348 MGB Alert® HSV Primer Mix contains chemically synthesized DNA oligonucleotides d MGB Alert® HSV Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HSV (Herpes Simplex Virus). The mix consists of a total of 24.8 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 141 nucleic acid sequence from the glycoprotein D region of HSV MVU Reagents, Specific, Analyte 1 MGB Alert HSV Ensemble Primer Mix ASR - 480 rxn
50 03661540951282 800333 800333 "MGB Alert® BK Virus Probe Mix is an analyte specific reagent that contains a ch "MGB Alert® BK Virus Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleicacid sequences from BK Virus. The mix consists of one probe at 1.5 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm." MVU Reagents, Specific, Analyte 1 MGB Alert® BKV Probe Mix ASR-480rxn
Other products with the same Product Code "OOI"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00628055344179 410400 410400 The Revogene® Strep A assay, performed on the Revogene® instrument, is an automa The Revogene® Strep A assay, performed on the Revogene® instrument, is an automated, qualitative in vitro diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Streptococcus pyogenes (Group A B-hemolytic Streptococcus) nucleic acids from throat swab specimens obtained from patients with signs and symptoms of pharyngitis. The Revogene Strep A assay is intended for use as an aid in the diagnosis of Group A Streptococcus infection. Revogene® Strep A MERIDIAN BIOSCIENCE CANADA INC
2 00628055344162 410500 410500 The Revogene® Carba C assay, performed on the Revogene® instrument, is a qualita The Revogene® Carba C assay, performed on the Revogene® instrument, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48-like, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. The test utilizes automated real-time Polymerase Chain Reaction (PCR).The Revogene Carba C assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. A negative Revogene Carba C assay result does not preclude the presence of other resistance mechanisms.The Revogene Carba C assay is intended as an aid for infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. The identification of a blaIMP, blaNDM or blaVIM metallo-B-lactamase gene (i.e., the genes that encode the IMP, NDM and VIM metallo-B-lactamases, respectively) may be used as an aid to clinicians in determining appropriate therapeutic strategies for patients with known or suspected carbapenem non-susceptible infections. Revogene® Carba C MERIDIAN BIOSCIENCE CANADA INC
3 00628055344131 610208 610208 The MOCK PIE is a re-usable PIE intended for use in conjunction with the Revogen The MOCK PIE is a re-usable PIE intended for use in conjunction with the Revogene® instrument and Revogene® assays. The MOCK PIE simulates the presence of an assay PIE for thermal and rotational balance when the number of assay PIEs is lower than eight in a run. MOCK PIE MERIDIAN BIOSCIENCE CANADA INC
4 00628055344117 410200 410200 The Revogene® GBS LB assay performed on the Revogene instrument is a qualitative The Revogene® GBS LB assay performed on the Revogene instrument is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from 18-24 hour LIM broth enrichments of vaginal/rectal specimen swabs obtained from pregnant women. The Revogene GBS LB assay utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome.The Revogene GBS LB assay is indicated for the identification of antepartum GBS colonization and does not provide susceptibility results. It is not intended to diagnose or monitor treatment of GBS infection. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women. Revogene® GBS LB MERIDIAN BIOSCIENCE CANADA INC
5 00628055344100 610210 610210 The Revogene® instrument is intended for in vitro diagnostic (IVD) use in perfor The Revogene® instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assays in clinical laboratories. The Revogene is capable of automated lysis and dilution of samples originating from various clinical specimen types. The Revogene performs automated amplification and detection of target nucleic acid sequences by fluorescence-based real time PCR. Revogene® MERIDIAN BIOSCIENCE CANADA INC
6 00628055344087 133674 133674 The GenePOC Strep A assay, performed on the revogene instrument, is an automated The GenePOC Strep A assay, performed on the revogene instrument, is an automated, qualitative in vitro diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Streptococcus pyogenes (Group A B-hemolytic Streptococcus) nucleic acids from throat swab specimens obtained from patients with signs and symptoms of pharyngitis. The GenePOC Strep A assay is intended for use as an aid in the diagnosis of Group A Streptococcus infection. GenePOC™ Strep A GENEPOC INC
7 00628055344070 133499 133499 The GenePOC™ Carba assay, performed on the revogene™ instrument, is a qualitativ The GenePOC™ Carba assay, performed on the revogene™ instrument, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48-like, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. The test utilizes automated real-time Polymerase Chain Reaction (PCR).The GenePOC Carba assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. A negative GenePOC Carba assay result does not preclude the presence of other resistance mechanisms.The GenePOC Carba assay is intended as an aid for infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. The identification of a blaIMP, blaNDM or blaVIM metallo-B-lactamase gene (i.e., the genes that encode the IMP, NDM and VIM metallo-B-lactamases, respectively) may be used as an aid to clinicians in determining appropriate therapeutic strategies for patients with known or suspected carbapenem non-susceptible infections. GenePOC™ Carba GENEPOC INC
8 00628055344032 132331 132331 The MOCK PIE is a re-usable PIE intended for use in conjunction with the revogen The MOCK PIE is a re-usable PIE intended for use in conjunction with the revogene™ instrument and GenePOC assays. The MOCK PIE simulates the presence of an assay PIE for thermal and rotational balance when the number of assay PIEs is lower then eight in a run. MOCK PIE GENEPOC INC
9 00628055344001 130840 130840 The revogene™ instrument is intended for in vitro diagnostic (IVD) use in perfor The revogene™ instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assays in clinical laboratories. The revogene is capable of automated lysis and dilution of samples originating from various clinical specimen types. revogene performs automated amplification and detection of target nucleic acid sequences by fluorescence-based real-time PCR. revogene™ GENEPOC INC
10 00382904439859 443985 443985 BD MAX™ Enteric Viral Panel BD MAX™ Enteric Viral Panel BECTON, DICKINSON AND COMPANY
11 00382904437121 443712 443712 BD MAX™ Vaginal Panel BD MAX™ Vaginal Panel BECTON, DICKINSON AND COMPANY
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13 00382904434199 443419 443419 Kit BD MAX StaphSR BD MAX™ StaphSR BECTON, DICKINSON AND COMPANY
14 00382904433802 443380 443380 BD MAX™ Enteric Parasite Panel (US/CAN) Contains: 24 Master Mix, 24 Extraction T BD MAX™ Enteric Parasite Panel (US/CAN) Contains: 24 Master Mix, 24 Extraction Tubes, 24 1.5 mL Sample Buffer tubes, 25 Septum Caps, 24 Strips Containing, Wash Buffer, Elution Buffer, Neutralization Buffer BD MAX™ Enteric Parasite Panel (US/CAN) GENEOHM SCIENCES CANADA INC
15 00382904433789 443378 443378 Kit BD Max Enteric Bacterial Panel USA BD MAX™ Enteric Bacterial Panel (US/CAN) GENEOHM SCIENCES CANADA INC
16 00382904429638 442963 442963 Kit BD MAX Enteric Bacterial Panel BD MAX™ Enteric Bacterial Panel BECTON, DICKINSON AND COMPANY
17 00382904429607 442960 442960 BD MAX™Enteric Parasite Panel Contains: 24 Master Mix, 24 Extraction Tubes, 24 x BD MAX™Enteric Parasite Panel Contains: 24 Master Mix, 24 Extraction Tubes, 24 x 1.5mL Sample Buffer Tubes, 25 x Septum, 24 x Strips BD MAX™ Enteric Parasite Panel BECTON, DICKINSON AND COMPANY
18 00382904429584 442958 442958 BD Viper™ LT System SDA Accessory Kit BD Viper™ LT System SDA Accessory Kit BECTON, DICKINSON AND COMPANY
19 00382904429508 442950 442950 BD Pre-Warm Heater BD Pre-Warm Heater BECTON, DICKINSON AND COMPANY
20 00382904428396 442839 442839 BD Viper™ LT System BD Viper™ LT System BECTON, DICKINSON AND COMPANY
21 00382904419271 441927 441927 Instrument Max Clinical Refurb BD MAX™ Instrument, Remanufactured BECTON, DICKINSON AND COMPANY
22 00382904419165 441916 441916 Instrument Max Clinical BD MAX™ System, BD MAX™ Instrument BECTON, DICKINSON AND COMPANY
23 00382904417727 441772 441772 Kit BD Max GBS BD MAX™ GBS BECTON, DICKINSON AND COMPANY
24 B178GBSTEC100 GBSTEC-10 GBSTEC-10 Shiga Toxin Direct Test Cartridge with sample prep device. Shiga Toxin Direct Test GREAT BASIN SCIENTIFIC, INC.
25 B178GBSIDR100 GBSIDR-10 GBSIDR-10 Staph ID/R Blood Culture Panel GREAT BASIN SCIENTIFIC, INC.
26 B178GBSBPP100 GBSBPP-10 GBSBPP-10 Stool Bacterial Pathogens Panel Cartridge with sample prep device. Stool Bacterial Pathogens Panel GREAT BASIN SCIENTIFIC, INC.
27 B178GBGBS100 GBGBS-10 GBGBS-10 Group B Strep Assay GREAT BASIN SCIENTIFIC, INC.
28 B178GBBORD100 GBBORD-10 GBBORD-10 Bordetella Direct Test Cartridge Bordetella Direct Test GREAT BASIN SCIENTIFIC, INC.
29 40816101025082 MOL1451 Direct Amplification Disc DIASORIN MOLECULAR LLC
30 40816101025075 MOL1400 Universal Disc DIASORIN MOLECULAR LLC
31 30816101025092 MOL1455 Direct Amplification Disc Kit DIASORIN MOLECULAR LLC
32 30816101025085 MOL1451 Direct Amplification Disc DIASORIN MOLECULAR LLC
33 30816101025078 MOL1401 Universal Disc DIASORIN MOLECULAR LLC
34 30382904419944 441994 441994 BD Viper™ SDA Extraction Reagent Trough BD Viper™ SDA Extraction Reagent Trough BECTON, DICKINSON AND COMPANY
35 30382904375196 437519 437519 BD PCR Cartridges 24EA BD MAX™ PCR Cartridge BECTON, DICKINSON AND COMPANY
36 30014613311058 Direct C. difficile Assay M105 Lyra Direct CDIFF Assay Lyra QUIDEL CORPORATION
37 30014613311003 M100 M100 Lyra FLU A+B Assay Lyra DIAGNOSTIC HYBRIDS, INC.
38 20816101025651 MOL3560 MOL3560 Simplexa™ GBS Positive Control Pack DIASORIN MOLECULAR LLC
39 20816101025644 MOL3550 MOL3550 Simplexa™ GBS Direct DIASORIN MOLECULAR LLC
40 16974900600091 SWSI-02 Shineway ZHUHAI SHINEWAY BIOTECH CO.,LTD
41 16974900600039 SWM-02 Shineway ZHUHAI SHINEWAY BIOTECH CO.,LTD
42 15420045506398 PROPARAFLU+ KIT, 100 REACTIONS 303677 PRODESSE HOLOGIC, INC.
43 15420045506374 PROFAST+ KIT, 100 REACTIONS 303673 PRODESSE HOLOGIC, INC.
44 10816101025111 MOL1500 Universal Disc Cover Tape DIASORIN MOLECULAR LLC
45 10816101025036 MOL1011-P Integrated Cycler (220V) Pre-Owned DIASORIN MOLECULAR LLC
46 10816101025029 MOL1011 Integrated Cycler (220V) DIASORIN MOLECULAR LLC
47 10816101025012 MOL1001-P Integrated Cyler (110V) Pre-Owned DIASORIN MOLECULAR LLC
48 10816101025005 MOL1001 Integrated Cyler (110V) DIASORIN MOLECULAR LLC
49 10814278020724 500200 500200 NeuMoDx™ 96 Molecular System NeuMoDx™ 96 Molecular System NEUMODX MOLECULAR, INC.
50 10814278020014 500100 500100 NeuMoDx™ 288 Molecular System NeuMoDx™ 288 Molecular System NEUMODX MOLECULAR, INC.